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Disorder of Maxillary SinusNCT02583737

Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting

A study testing freeze bone allograft and lyophilized bone allograft in people with Disorder of Maxillary Sinus and Accessory; Bone, run by University of Sao Paulo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
What is being tested?
freeze bone allograft and lyophilized bone allograft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Jun 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy
  • totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.

Who cannot join

  • recent sinusitis history
  • hypersensibility for sinus allergens, tabagism, ethylism
  • severe periodontal disease, diabetes, hypertension.
  • Cases that occur schneiderian membrane perforation will be excluded from the final sample.

About this study

Official title: Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial

Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).

Being tested
freeze bone allograft, lyophilized bone allograft
Keywords
bone, maxillary sinus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • freeze bone allograftProcedure or surgery

    sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.

  • lyophilized bone allograftProcedure or surgery

    sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.

Study groups in NCT02583737
Study groupRoleWhat they receive
group lyophilized bone allograftActive comparatorsinus lifting with tissue bank lyophilized bone filling
Receives: Procedure: lyophilized bone allograft
group freeze bone allograftActive comparatorsinus lifting with freeze bone bank filling
Receives: Procedure: freeze bone allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. volume of bone neoformation in mm3

    computational software for analysis the micro CT scanning of trephine bone samples images

    Measured: six months after grafting

  2. area of bone neoformation in μm2

    IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images

    Measured: six months after grafting

Secondary outcomes (2)

  1. dental implants stability value

    primary implant stability by Resonance Frequency Analysis (RFA) in ISQ

    Measured: six months after grafting

  2. dental implants stability value

    late stability by Resonance Frequency analysis (RFA) in ISQ

    Measured: six months after dental implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02583737
Sponsor's protocol ID
CAEE 30738714.0.0000.0075.
Status last verified
May 2016
First submitted
19 Oct 2015
Last updated
11 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Acocella A, Bertolai R, Nissan J, Sacco R. Clinical, histological and histomorphometrical study of maxillary sinus augmentation using cortico-cancellous fresh frozen bone chips. J Craniomaxillofac Surg. 2011 Apr;39(3):192-9. doi: 10.1016/j.jcms.2010.03.019. Epub 2010 May 7.

    PubMed 20452232

  • Chiapasco M, Giammattei M, Carmagnola D, Autelitano L, Rabbiosi D, Dellavia C. Iliac crest fresh-frozen allografts and autografts in maxillary and mandibular reconstruction: a histologic and histomorphometric evaluation. Minerva Stomatol. 2013 Jan-Feb;62(1-2):3-16. English, Italian.

    PubMed 23422679

  • de Castilho TR, Tortamano P, Marotti J, de Andrade JC Jr, Chilvarquer I, Ximenez ME, Alves MT. Clinical and Histomorphometric Evaluation of Fresh Frozen Bone Allograft in Sinus Lift Surgery. Clin Implant Dent Relat Res. 2016 Feb;18(1):40-50. doi: 10.1111/cid.12234. Epub 2014 Jun 6.

    PubMed 24909241

  • Deluiz D, Oliveira LS, Pires FR, Tinoco EM. Time-dependent changes in fresh-frozen bone block grafts: tomographic, histologic, and histomorphometric findings. Clin Implant Dent Relat Res. 2015 Apr;17(2):296-306. doi: 10.1111/cid.12108. Epub 2013 Jul 9.

    PubMed 23837530

  • Eskan MA, Greenwell H, Hill M, Morton D, Vidal R, Shumway B, Girouard ME. Platelet-rich plasma-assisted guided bone regeneration for ridge augmentation: a randomized, controlled clinical trial. J Periodontol. 2014 May;85(5):661-8. doi: 10.1902/jop.2013.130260. Epub 2013 Jul 29.

    PubMed 23895252

  • Goulet JA, Senunas LE, DeSilva GL, Greenfield ML. Autogenous iliac crest bone graft. Complications and functional assessment. Clin Orthop Relat Res. 1997 Jun;(339):76-81. doi: 10.1097/00003086-199706000-00011.

    PubMed 9186204

  • Holtzclaw D, Toscano N, Eisenlohr L, Callan D. The safety of bone allografts used in dentistry: a review. J Am Dent Assoc. 2008 Sep;139(9):1192-9. doi: 10.14219/jada.archive.2008.0334.

    PubMed 18762629

  • Le B, Rohrer MD, Prasad HS. Screw "tent-pole" grafting technique for reconstruction of large vertical alveolar ridge defects using human mineralized allograft for implant site preparation. J Oral Maxillofac Surg. 2010 Feb;68(2):428-35. doi: 10.1016/j.joms.2009.04.059. Epub 2010 Jan 15.

    PubMed 20116718

  • Pimentel AC, Napimoga MH, Manzi MR, Sendyk WR. Reconstruction of the edentulous mandible with fresh frozen bone grafts and implants: a 4-year report of a prospective clinical study. Cell Tissue Bank. 2014 Mar;15(1):1-6. doi: 10.1007/s10561-012-9352-y. Epub 2012 Nov 27.

    PubMed 23184222

  • Pelegrine AA, Sorgi da Costa CE, Sendyk WR, Gromatzky A. The comparative analysis of homologous fresh frozen bone and autogenous bone graft, associated or not with autogenous bone marrow, in rabbit calvaria: a clinical and histomorphometric study. Cell Tissue Bank. 2011 Aug;12(3):171-84. doi: 10.1007/s10561-010-9178-4. Epub 2010 May 16.

    PubMed 20473718

  • Schwartz Z, Goldstein M, Raviv E, Hirsch A, Ranly DM, Boyan BD. Clinical evaluation of demineralized bone allograft in a hyaluronic acid carrier for sinus lift augmentation in humans: a computed tomography and histomorphometric study. Clin Oral Implants Res. 2007 Apr;18(2):204-11. doi: 10.1111/j.1600-0501.2006.01303.x.

    PubMed 17348885

Questions about this trial

What is this clinical trial studying?

A study testing freeze bone allograft and lyophilized bone allograft in people with Disorder of Maxillary Sinus and Accessory; Bone, run by University of Sao Paulo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volume of bone neoformation in mm3 (time frame: six months after grafting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02583737, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.

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